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Manager - Manufacturing Systems Integration Lead - IT

Zydus Group

Responsibilities

  • Key Responsibilities 1.
  • Plant Application Integration Ownership Own the integration strategy, roadmap, and landscape for all plant applications across sites.

Maintain a complete integration inventory

  • interfaces, data flows, owners, protocols, GxP impact, criticality, and support model.
  • Define integration standards, patterns, naming conventions, and reusable templates for consistent multi-site rollouts.
  • Act as design authority for all plant application interfaces, reviewing and approving designs from project teams and vendors.
  • 2.
  • End-to-End Manufacturing Process Integration Design and deliver integrations supporting core manufacturing business flows, including: ERP to MES: process orders, recipes/master data, material master, BOM, and routing download MES to ERP: material consumption, goods movements, yield, order confirmations, and batch status WMS/ERP to MES: dispensing, material staging, and inventory status MES to automation (DCS/PLC/SCADA): recipe parameters, equipment status, and process data Historian to MES/eBR: critical process parameters and batch context LIMS to ERP/MES: sample creation, test results, usage decisions, and batch disposition QMS integration: deviations, CAPA, and change control linked to batches and equipment CMMS/EAM integration: equipment status, calibration, maintenance, and logbook data Serialization/track-and-trace (L1–L5): line-level serialization, site server, and corporate/regulatory reporting Environmental monitoring and BMS: cleanroom, HVAC, and storage condition data Document management systems: master batch records, SOPs, and effective document versions Ensure integrations support batch record review, review by exception, and faster batch release.
  • 3.
  • Integration Design and Technical Leadership Lead integration design using appropriate patterns: real-time, event-driven, batch, file-based, and API-based.
  • Define interface specifications (ICDs), data mapping, transformation rules, error handling, retries, reconciliation, and alerting.
  • Guide implementation on middleware and integration platforms such as SAP PI/PO, SAP Integration Suite, SAP PCo, MuleSoft, Boomi, Azure Integration Services, Kafka, or vendor-specific connectors.
  • Apply industrial standards including ISA-95, ISA-88, B2MML, OPC UA, and MQTT where relevant.
  • Work closely with the IT-OT Integration Architect, Historian Architect, MES and LIMS leads, and OT security to ensure designs are secure, scalable, and aligned with the Purdue model.
  • Ensure master data consistency (materials, equipment, recipes, sites, units of measure) across integrated systems.
  • 4.
  • Project Delivery and Implementation Lead the integration workstream for new plant application implementations, upgrades, migrations, and site rollouts.
  • Plan integration scope, effort, timelines, dependencies, and resources with project managers and vendors.
  • Coordinate system integration testing (SIT), end-to-end process testing, and support UAT with business users.
  • Plan cutover, data migration, and go-live activities around production schedules and shutdowns.
  • Provide hypercare after go-live and hand over to support teams with complete documentation.
  • 5.
  • GxP Compliance, Validation and Data Integrity Ensure all integrations comply with 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ principles.
  • Classify interfaces by GxP impact and apply risk-based validation (CSV/CSA).
  • Author or review interface URS, functional and design specifications, risk assessments, test protocols (IQ/OQ/PQ), and traceability matrices.
  • Design controls for data completeness and accuracy, including reconciliation, duplicate prevention, audit trails, failure alerts, and manual fallback procedures.
  • Support change control, periodic reviews, and regulatory inspections (USFDA, EMA, MHRA, WHO-GMP) as the integration SME.
  • Ensure multi-site integrations maintain clear site-level separation of data and responsibilities.
  • 6.
  • Integration Operations and Support Establish integration monitoring, dashboards, and alerting for interface health, message failures, and backlogs.
  • Act as the escalation point for integration incidents and lead root cause analysis.
  • Define support processes, SLAs, runbooks, and error-handling procedures with IT operations and site teams.
  • Drive continuous improvement to reduce interface failures and manual workarounds.
  • 7.
  • Stakeholder and Team Leadership Partner with Manufacturing, QA, QC, Engineering, Warehouse, Supply Chain, and IT stakeholders to understand requirements and priorities.
  • Lead and mentor integration developers, analysts, and consultants.
  • Manage system integrators and application vendors on scope, quality, and delivery timelines.
  • Report integration status, risks, and performance to IT and business leadership.

Requirements

  • Strong understanding of pharma manufacturing processes : process orders, dispensing, batch execution, IPC, BMR/eBR, sampling and testing, batch review and release, deviations, and equipment management.
  • Hands-on integration experience with plant applications such as: MES: Körber PAS-X, Emerson Syncade, Siemens Opcenter, Rockwell PharmaSuite, or similar LIMS: LabWare, LabVantage, STARLIMS, Waters Empower (CDS) ERP: SAP ECC/S/4HANA (PP-PI, QM, MM, WM/EWM, PM) Historian: AVEVA PI, AspenTech IP.21, Honeywell PHD, or similar QMS/DMS: TrackWise, Veeva Vault, MasterControl, Documentum Serialization: Systech, TraceLink, Optel, Antares, rfxcel Experience with integration platforms and middleware (SAP PI/PO/CPI, SAP PCo/MII, MuleSoft, Boomi, Azure Integration Services, Kafka).
  • Strong knowledge of APIs (REST/SOAP), message queues, IDocs, file-based interfaces, and data mapping.
  • Knowledge of ISA-95, ISA-88, B2MML, and OPC UA.
  • Proven delivery of validated GxP integrations in regulated manufacturing.
  • Working knowledge of SQL and scripting (Python, PowerShell, or similar) for troubleshooting and data reconciliation.

Preferred

  • Bachelor's or Master's degree in Engineering (Computer, Instrumentation, Chemical, Electronics), Pharmacy, or Information Technology.
  • Certifications such as SAP Integration, MuleSoft, Azure Integration, PMP/PRINCE2, ITIL, or ISA-95/MESA.
  • Experience with multi-site or global plant application rollouts and Pharma 4.0 initiatives.
  • Exposure to cloud integration, data platforms, and AI/analytics use cases built on manufacturing data.

Role details

Plant Applications Integration Lead (Pharma Manufacturing) Role: Plant Applications Integration Lead Team: Manufacturing IT / Digital Manufacturing Experience: 10–15 years total, with at least 5 years integrating plant applications in pharma or regulated manufacturing, and at least 3 years in a lead role Domain: Pharma / Biotech / Life Sciences Manufacturing (GxP-regulated) Employment Type: Full-time Role Summary